Relsed

Leaflet attached to the packaging: patient information

RELSED, 5 mg/2.5 ml rectal microenema, solution

RELSED, 10 mg/2.5 ml rectal microenema, solution

Diazepam

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Relsed and what is it used for
• 2. Important information before using Relsed
• 3. How to use Relsed
• 4. Possible side effects
• 5. How to store Relsed
• 6. Contents of the packaging and other information

1. What is Relsed and what is it used for

Relsed contains the active substance diazepam. Diazepam belongs to a group of medicines called benzodiazepines. It has anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant properties.
Relsed is used rectally:

• in febrile seizures (seizures occurring during high fever);
• in prolonged or frequently recurring epileptic seizures (status epilepticus);
• in seizures occurring in eclampsia (called eclampsia);
• in anxiety attacks;
• in conditions characterized by increased muscle tension, including tetanus;
• in preparing the patient (premedication) before various procedures, e.g. before surgery, endoscopy;
• in the postoperative period to calm the patient.

2. Important information before using Relsed

When not to use Relsed

• if the patient is hypersensitive to diazepam or other benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• myasthenia gravis (a chronic disease characterized by muscle weakness);
• severe respiratory failure (severe breathing difficulties);
• sleep apnea syndrome (characterized by short pauses in breathing during sleep);
• severe liver failure (severe liver dysfunction);
• phobias (fear of specific objects or situations) or obsessions (obsessive, recurring thoughts or behaviors).
• Relsed should not be used as the only medicine in the treatment of depression or anxiety associated with depression.

Warnings and precautions

Before starting treatment with Relsed, the patient should discuss it with their doctor.
Patients should consult their doctor if they:

• are elderly, frail;
• have liver or kidney failure;
• have brain damage resulting from, for example, injury, atherosclerosis, stroke;
• have impaired motor function (called dyskinesia);
• have personality disorders;
• have chronic respiratory failure (even of moderate severity);
• have prostatic hyperplasia (with urinary retention);
• are addicted to drugs or alcohol;
• have glaucoma (increased eye pressure). Patients with these diseases should inform their doctor.

The patient should follow the doctor's instructions for the duration of treatment with Relsed. Treatment with Relsed should be as short as possible.

The patient should not use the medicine for a long time, as this may increase the risk of dependence and tolerance to the medicine. Tolerance development means that the medicine's effect weakens over time, requiring an increase in dosage.

Children

• The medicine should not be used in newborns, especially premature babies, due to the presence of benzyl alcohol - see section 2. "Relsed contains benzyl alcohol, ethanol, sodium benzoate, propylene glycol, and sodium".
• In infants up to 6 months of age, the medicine can only be used in life-threatening conditions - in such cases, the medicine is administered by medical personnel.
• The medicine can be used in children from 7 months of age (see section 3. "How to use Relsed").
• When using Relsed in children, so-called paradoxical reactions (symptoms listed in section 4. "Possible side effects") may occur. If these symptoms occur, the medicine should be discontinued.

Relsed and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Relsed and other medicines used at the same time may affect each other's action.
In particular, this applies to the following medicines listed below:

• strong painkillers (called opioid painkillers, e.g. morphine, buprenorphine); if diazepam is to be administered with opioid painkillers, diazepam should be administered last;
• medicines used in mental disorders (e.g. haloperidol);
• medicines used in the treatment of depression (fluoxetine, fluvoxamine);
• sedatives, anxiolytics, and hypnotics;
• anticonvulsants (e.g. phenobarbital);
• anesthetics and some medicines used in the treatment of allergies (with a sedative effect);
• cimetidine and omeprazole (medicines used in the treatment of peptic ulcer disease);
• disulfiram (a medicine used in the treatment of alcoholism);
• isoniazid (a medicine used in the treatment of tuberculosis);
• oral contraceptives;
• theophylline (a medicine used in the treatment of asthma);
• levodopa (a medicine used in the treatment of Parkinson's disease);
• muscle relaxants (e.g. baclofen);
• phenytoin (a medicine used in the treatment of epilepsy).

Concomitant use of Relsed and opioids (strong painkillers, drugs used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use of these medicines can only be considered if other treatment options are not possible.
If the doctor has prescribed Relsed together with opioid medicines, the doctor should reduce the dose and recommend the shortest possible treatment time.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the dosage instructions. It may be helpful to inform friends or relatives about the risk, so they are aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.

Relsed and alcohol (ethanol)

Alcohol (ethanol) enhances the sedative effect of diazepam. The patient should not drink alcohol while using Relsed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Relsed should not be used in pregnant women, especially during the first and third trimesters, and during breastfeeding, unless the doctor considers it necessary.

Driving and operating machinery

After using the medicine, the patient may experience sedation, concentration disorders, and other side effects that may adversely affect the performance of tasks requiring increased attention. The patient should not drive vehicles or operate machinery for at least 24 hours after administering Relsed.

Relsed contains benzyl alcohol, ethanol, sodium benzoate, propylene glycol, and sodium

The medicine contains 15 mg of benzyl alcohol per 1 ml of solution. Benzyl alcohol may cause allergic reactions.
Administering benzyl alcohol to newborns is associated with a risk of severe side effects, including breathing disorders (so-called "gasping syndrome").
The medicine should not be administered to newborns without a doctor's recommendation.
The medicine should not be administered to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Patients with kidney or liver dysfunction, as well as pregnant or breastfeeding women, should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
The medicine contains 12.4% v/v ethanol (alcohol), i.e. up to 250 mg per microenema, which is equivalent to 5.94 ml of beer or 2.48 ml of wine per microenema.
Harmful to people with alcoholism.
This should be taken into account when using the medicine in pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy.
The medicine contains 48.8 mg of sodium benzoate per 1 ml of solution. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
The medicine contains 19.5 mg of sodium (the main component of table salt) per microenema (7.8 mg of sodium per 1 ml). This corresponds to 0.96% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 400 mg of propylene glycol in each 1 ml (1000 mg per microenema).
Before administering the medicine to a child under 5 years of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Pregnant or breastfeeding women, patients with kidney or liver dysfunction should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.

3. How to use Relsed

This medicine should always be used in accordance with the doctor's instructions. In case of doubts, the patient should consult their doctor.

• The medicine is for rectal use only.
• Relsed has packaging designed for rectal administration, called a microenema. The microenema is a polyethylene tube with a rectal cannula, allowing the medicine to be administered.
• The doctor will determine the dosage and duration of treatment individually for each patient. The patient should strictly follow the doctor's instructions.
• If the medicine is used at home, it should be administered to the patient by a responsible adult. The patient should be accompanied until the symptoms subside.
• The effect of the medicine is visible 5-10 minutes after administration.

A 2.5 ml rectal microenema of Relsed (2 mg/ml) contains 5 mg of diazepam.
A 2.5 ml rectal microenema of Relsed (4 mg/ml) contains 10 mg of diazepam.

Adults

Initially: 1 microenema of 5 mg of diazepam or 1 microenema of 10 mg of diazepam.
If the symptoms do not subside, the dose can be repeated after about 10-15 minutes. If the patient's condition does not improve, the patient should call their doctor.
Before procedures and in the postoperative period:

• on the day before the procedure: 2 to 4 microenemas of 5 mg or 1 to 2 microenemas of 10 mg of diazepam;
• 30-60 minutes before surgery: 1 to 2 microenemas of 5 mg or 1 microenema of 10 mg of diazepam;
• after surgery: 1 to 2 microenemas of 5 mg or 1 microenema of 10 mg of diazepam.

Children

The doctor will inform the child's caregiver about the situations in which the medicine should be administered (type of seizure, duration) and determine the dose suitable for the child.
Usually used doses:

• infants from 7 months of age: up to 0.5 mg/kg of body weight;
• children with a body weight of 10-15 kg: 1 microenema of 5 mg of diazepam;
• children with a body weight over 15 kg: 2 microenemas of 5 mg or 1 microenema of 10 mg of diazepam. If the seizures do not subside, the dose can be repeated after 10-15 minutes. If the child's condition does not improve, the patient should call their doctor.

In the case of febrile seizures, children with a high risk of recurrence of seizures, the doctor may recommend administering the medicine in microenemas every 8 hours, if the fever persists above 38.5°C.
The patient should always strictly follow the doctor's instructions.

Method of administration

During and for 15 minutes after administering the medicine, the patient should lie horizontally, on their stomach. A small child can be placed on the caregiver's knees.

• 1. Tear off the foil and remove the microenema.
• 2. Lubricate the cannula with a lubricating gel (available at the pharmacy), which will facilitate the introduction of the cannula into the rectum.
• 3. Open the microenema by twisting the cannula tip.
• 4. Insert the cannula into the rectum (in the case of small children, insert the cannula only halfway, in the case of older children and adults, insert the entire cannula).
• 5. Empty the reservoir by pressing the thumb and index finger firmly.
• 6. Remove the cannula from the rectum without releasing the pressure on the reservoir.
• 7. Squeeze the buttocks for a few minutes to prevent the medicine from leaking out.

Using a higher dose of Relsed than recommended

After overdosing on diazepam, the patient may experience: drowsiness, confusion (disorders of consciousness, disorientation, anxiety). In more severe cases, the patient may also experience impaired motor function, decreased blood pressure, muscle weakness, breathing difficulties, and coma. If a higher dose of the medicine than recommended is used, the patient should immediately consult their doctor, who will administer the appropriate treatment.

If a dose of Relsed is missed

The patient should not use a double dose to make up for the missed dose.

Stopping treatment with Relsed

After stopping treatment with Relsed, the patient may experience symptoms of so-called withdrawal syndrome, although its occurrence is unlikely, as the medicine is used on an as-needed basis. The symptoms of the syndrome include: headache and muscle pain, anxiety, tension, restlessness, confusion, and in severe cases - loss of consciousness, depersonalization (feeling of uncertainty or unreality of one's personality), increased sensitivity to sound and light, numbness and tingling of limbs, increased sensitivity to light and noise, hallucinations, and epileptic seizures.
After stopping treatment, the patient may experience a so-called rebound phenomenon (symptoms of the disease may return after stopping the medicine). The symptoms of this phenomenon are: mood changes, anxiety, difficulty falling asleep, restlessness.
Therefore, the medicine should be discontinued gradually, reducing the doses. The doctor will inform the patient how to stop using Relsed to minimize the risk of these symptoms.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Relsed can cause side effects, although not everybody gets them.
After using the medicine, side effects are usually mild and rare.
The patient may experience: sedation, drowsiness, impaired motor function, muscle weakness.
Rarely, the patient may experience:

• pain and dizziness, vision disorders, disorientation, anterograde amnesia (the patient does not remember events that occurred in the short time after administering the medicine), speech disorders;
• breathing difficulties, laryngospasm, apnea, chest pain;
• decreased blood pressure, bradycardia, changes in blood test results (visible in the so-called morphology test);
• gastrointestinal disorders (dry mouth, increased appetite, jaundice);
• changes in libido, menstrual disorders;
• urinary retention;
• skin allergic reactions;
• fatigue, tremors.

After using diazepam (especially in children and elderly patients), the patient may experience: restlessness, agitation, hallucinations, changes in behavior, aggression, nightmares, psychoses (so-called paradoxical reactions).
In elderly and frail patients, the patient may experience increased side effects.
After using diazepam, latent depression may be revealed.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Relsed

Store in a temperature below 25°C.
The medicine should be stored in a place that is invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the carton and microenema.
The expiry date stated on the packaging means the last day of the given month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Relsed 5 mg/2.5 ml contain, rectal microenema

• The active substance of the medicine is diazepam. Each 1 ml of solution contains 2 mg of diazepam.
• The other ingredients are: ethanol 96%, benzyl alcohol (15 mg/ml), propylene glycol, sodium benzoate, glacial acetic acid, purified water. A 2.5 ml rectal microenema contains 5 mg of diazepam.

What does Relsed 10 mg/2.5 ml contain, rectal microenema

• The active substance of the medicine is diazepam. Each 1 ml of solution contains 4 mg of diazepam.
• The other ingredients are: ethanol 96%, benzyl alcohol (15 mg/ml), propylene glycol, sodium benzoate, glacial acetic acid, purified water. A 2.5 ml rectal microenema contains 10 mg of diazepam.

What Relsed looks like and what the packaging contains

Relsed is a clear, colorless to yellowish-green liquid.
The carton contains 5 microenemas (polyethylene tube with a rectal cannula) of 2.5 ml each.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz
Date of last revision of the leaflet:December 2024